Lexicon Pharmaceuticals, Inc. of THE WOODLANDS, Texas, has announced that the U.S. Food and Drug Administration (“FDA”) will require additional time to complete its review of the New Drug Application (“NDA”) for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. In a notice received from the FDA, the Prescription Drug User Fee Act (“PDUFA”) date for its Priority Review of telotristat etiprate has been extended by three months, from November 30, 2016 to February 28, 2017. In response to an information request from the FDA, additional clinical data analyses have been submitted and the extension will provide the FDA time for a full review of the submission.
“We look forward to continuing to work closely with the FDA throughout the remainder of the regulatory review of telotristat etiprate,” said Lexicon President and Chief Executive Officer, Lonnel Coats. “We appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we are committed to bringing this potential new therapy to patients suffering from carcinoid syndrome.”
Carcinoid syndrome is a rare disease affecting thousands of cancer patients with metastatic neuroendocrine tumors (mNETs) that have spread to the liver and other organs from the gastrointestinal tract. The condition is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as facial flushing, abdominal pain, fatigue and, over time, heart valve damage.
About Telotristat Etiprate
Discovered using Lexicon’s unique approach to gene science, telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome. While existing treatments for carcinoid syndrome work to reduce the release of serotonin outside tumor cells, telotristat etiprate works at the source to reduce serotonin production within the tumor cells. By specifically inhibiting serotonin production, telotristat etiprate seeks to control this important driver of carcinoid syndrome and, in turn, provide patients with more control over their disease.
Telotristat etiprate has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and has been granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2017.
Lexicon retains rights to market telotristat etiprate in the U.S. and Japan, and is building the in-house commercial infrastructure to serve the U.S. market. Lexicon has a license and collaboration agreement with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. – PRNewswire